Anlotinib as a third-line therapy in patients with refractory advanced non-small-cell lung cancer: a multicentre, randomised phase II trial (ALTER0302)
机构：[1]Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai 230030, China[2]Tianjin Medical University Cancer Hospital, Tianjin 300040, China[3]Beijing Chest Hospital, Capital Medical University, Beijing 101149, China[4]Jilin Province Tumor Hospital, Changchun 130012, China[5]The First Affiliated Hospital, Medical School of Zhejiang University, Hangzhou 310009, China浙江大学医学院附属第一医院[6]West China Hospital, Sichuan University, Chengdu 610041, China四川大学华西医院[7]Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing 100021, China[8]Shandong Cancer Hospital, Jinan 250117, China[9]Hunan Cancer Hospital, Changsha 220633, China[10]Zhejiang Cancer Hospital, Hangzhou 310022, China浙江省肿瘤医院[11]Fujian Cancer Hospital, Fuzhou 350001, China[12]Changhai Hospital, Second Military Medical University, Shanghai 200433, China[13]The Second Affiliated Hospital, Third Military Medical University, Chongqing 400037, China
Background: Anlotinib (AL3818) is a novel multitarget tyrosine kinase inhibitor, inhibiting tumour angiogenesis and proliferative signalling. The objective of this study was to assess the safety and efficacy of third-line anlotinib for patients with refractory advanced non-small-cell lung cancer (RA-NSCLC). Methods: Eligible patients were randomised 1 : 1 to receive anlotinib (12mg per day, per os; days 1-14; 21 days per cycle) or a placebo. The primary end point was progression-free survival (PFS). Results: A total of 117 eligible patients enrolled from 13 clinical centres in China were analysed in the full analysis set. No patients received immune check-point inhibitors and epidermal growth factor receptor status was unknown in 60.7% of the population. PFS was better with anlotinib compared with the placebo (4.8 vs 1.2 months; hazard ratio (HR) = 0.32; 95% confidence interval (CI), 0.20-0.51; P<0.0001), as well as overall response rate (ORR) (10.0%; 95% CI, 2.4-17.6% vs 0%; 95% CI, 0-6.27%; P = 0.028). The median overall survival (OS) was 9.3 months (95% CI, 6.8-15.1) for the anlotinib group and 6.3 months (95% CI, 4.3-10.5) for the placebo group (HR = 0.78; 95% CI, 0.51-1.18; P = 0.2316). Adverse events were more frequent in the anlotinib than the placebo group. The percentage of grade 3-4 treatment-related adverse events was 21.67% in the anlotinib group. Conclusions: Anlotinib as a third-line treatment provided significant PFS benefits to patients with RA-NSCLC when compared with the placebo, and the toxicity profiles showed good tolerance.
基金：
This study was funded by Chia Tai Tianqing Pharmaceutical
Group Co., Ltd, Nanjing, Jiangsu Province, China. We acknowledge
the invaluable participation of the patients.
第一作者机构：[1]Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai 230030, China
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推荐引用方式(GB/T 7714)：
Baohui Han,Kai Li,Yizhuo Zhao,et al.Anlotinib as a third-line therapy in patients with refractory advanced non-small-cell lung cancer: a multicentre, randomised phase II trial (ALTER0302)[J].British journal of cancer.2018,118(5):654-661.doi:10.1038/bjc.2017.478.
APA：
Baohui Han,Kai Li,Yizhuo Zhao,Baolan Li,Ying Cheng...&Guoming Wu.(2018).Anlotinib as a third-line therapy in patients with refractory advanced non-small-cell lung cancer: a multicentre, randomised phase II trial (ALTER0302).British journal of cancer,118,(5)
MLA：
Baohui Han,et al."Anlotinib as a third-line therapy in patients with refractory advanced non-small-cell lung cancer: a multicentre, randomised phase II trial (ALTER0302)".British journal of cancer 118..5(2018):654-661
医学